Class 2 Device Recall Sizing Balloon II

• Date Initiated by Firm: December 17, 2010
• Date Posted: March 08, 2011
• Recall Status: Terminated on March 29, 2012
• Recall Number: Z-1595-2011
• Recall Event ID: 57819
• 510(K)Number: K053440
• Product Classification: Catheter, intravascular occluding, temporary - Product Code MJN
• Product: AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
• Code Information: Lot 10004282114
• Recalling Firm/ Manufacturer: AGA Medical Corporation; 5050 Nathan Ln N; Plymouth MN 55442-3209
• For Additional Information Contact: Kate Stoltenberg; 651-756-6293
• Manufacturer Reason for Recall: AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.
• FDA Determined Cause: Employee error
• Action: AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA. For questions regarding this recall call 1-763-531-3175.
• Quantity in Commerce: 54
• Distribution: Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MJN